The TiLink-P SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Device Description

The TiLink-P SI Joint Fusion System contains various orthopedic instruments to assist the user in implanting a titanium sacroiliac implant into the sacroiliac joint to transfix the joint.

The SurGenTec TiLink-P SI Joint Fixation System includes TiLink Implants and associated Instruments. The TiLink Implant may be used standalone. The TiLink Implants are manufactured from titanium alloy and include the TiLink Locking Screw and the TiLink Compression Anchor. The TiLink Compression Anchor is designed to transfix the ilium and sacrum while compressing the SI joint. The TiLink Compression Anchor includes an opening to insert the TiLink Locking Screw. During the Procedure, the TiLink Compression Anchor is positioned so that it spans the ilium and sacrum, the TiLink Locking Screw is inserted through the TiLink Compression Anchor via a posterior approach. Bone graft material is placed within the TiLink implant to facilitate bone growth.

The SurGenTec TiLink-P SI Joint System may be provided sterile single-use or non-sterile.

AI/ML Overview

This document describes an FDA 510(k) clearance for a medical device, the "TiLink-P SI Joint Fusion System." The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process typically involves performance testing to show the new device meets the same safety and effectiveness standards as the predicate.

However, the provided text does not contain any information about an AI/ML-based device or a study involving AI assistance for human readers. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to the mechanical, material, and biological properties of the physical implant device (TiLink-P SI Joint Fusion System), not the performance of an AI algorithm or its impact on human readers.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study for an AI device. The text focuses on:

Device Name: TiLink-P SI Joint Fusion System
Intended Use: Sacroiliac joint fusion
Materials: Titanium alloy
Performance Testing:
- Dynamic vertical shear testing (ASTM F3574)
- Foam block pullout testing (ASTM F543)
- Biocompatibility (ISO 10993)
- Sterilization Validation

The closest thing to "acceptance criteria" in this context is that the device "met the pre-determined acceptance criteria for the verification activities" for these specific mechanical, biological, and sterilization tests. The "study" mentioned is the "Performance Testing" which consists of these engineering and and biocompatibility evaluations.

There is no information in the provided document about:

A table of acceptance criteria and reported device performance (in the context of AI metrics like sensitivity, specificity, etc.)
Sample sizes for AI test sets
Data provenance for AI data
Number of experts for AI ground truth
Adjudication methods for AI ground truth
MRMC comparative effectiveness study
Standalone AI performance
Type of ground truth for AI (expert consensus, pathology, etc.)
Sample size for AI training set
How AI training set ground truth was established

In summary, the provided document is for a physical medical implant device, not an AI/ML diagnostic or assistive tool. Thus, the specific criteria and study details requested for an AI device are not applicable to the information given.

Summary

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April 11, 2024

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SurGenTec, LLC Guilherme Pires Vice President of Operations 911 Clint Moore Rd Boca Raton, Florida 33487

Re: K240720

Trade/Device Name: TiLink-P SI Joint Fusion System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: OUR Dated: March 13, 2024 Received: March 15, 2024

Dear Guilherme Pires:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Colin O'neill -S

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

Submission Number (if known)

K240720

Device Name

TiLink-P SI Joint Fusion System

Indications for Use (Describe)

The TiLink-P SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Type of Use (Select one or both, as applicable)

< Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Device Trade Name:	TiLink-P SI Joint Fusion System
Manufacturer:	SurGenTec, LLC911 Clint Moore RdBoca Raton, FL 33487Telephone: 561-990-7882
Contact:	Mr. Guilherme PiresVice President of OperationsSurGenTec, LLC911 Clint Moore RdBoca Raton, FL 33487Phone: 561-990-7882Email: gui@surgentec.com
Date Prepared:	March 8, 2024
Regulation/Common Name:	21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener
Class:	II
Product Codes: Primary	OUR
Predicate:	TiLink-P SI Joint Fusion System (K230857)

Indications For Use:

The TiLink-P SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Device Description:

The TiLink-P SI Joint Fusion System contains various orthopedic instruments to assist the user in implanting a titanium sacroiliac implant into the sacroiliac joint to transfix the joint.

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The SurGenTec TiLink-P SI Joint System may be provided sterile single-use or non-sterile.

Substantial Equivalence:

The subject TiLink-P SI Joint Fusion System is substantially equivalent to the TiLink-P SI Joint Fusion System cleared in K230857 with respect to intended use, materials, design, and function. The information summarized in the Design Control Activities Summary demonstrates that the subject TiLink-P SI Joint Fusion System met the pre-determined acceptance criteria for the verification activities.

Performance Testing:

The following tests have been performed to establish substantial equivalence:

Dynamic vertical shear testing per ASTM F3574 and foam block ● pullout testing per ASTM F543
Biocompatibility per ISO 10993 ●
Sterilization Validation

Conclusion:

The information provided in this submission lead to the conclusion that the TiLink-P SI Joint Fusion System is substantially equivalent to the predicate device.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.